510(k) K181652

Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture by ETHICON, Inc. — Product Code GAM

K181652 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture". The FDA issued a decision of Substantially Equivalent on September 28, 2018. The device falls under product code GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid), a Class II device regulated under 21 CFR 878.4493. ETHICON, Inc. has at least 10 other 510(k) clearances on record.